PMTA Registries and 2023 Annual Reports

An emergent issue for 2024 in the nicotine space has been the introduction of PMTA registry bills in state legislatures across the U.S. These proposed laws (listed below) will create directories of ENDS/vapor products on a state-level that have been certified by ENDS manufacturers. Each state bill is slightly different in wording but the intent is to require all manufacturers of alternative nicotine products or vapor products to pay a fee and certify with some frequency that they have (among other possible stipulations) submitted PMTAs for their nicotine vapor products on or before September 9, 2020. These proposed laws generally provide the state with additional enforcement authorities and prohibit the sale of any nicotine vapor product not listed in the directory.

Assuming some of these laws pass, which has already occurred in Louisiana and Oklahoma (vape attestation and registry lists here), the maintenance of a directory of ENDS products could prove to be a challenge over time. FDA CTP is the only stakeholder with the “master list” of deemed new tobacco products with timely applications to include/exclude from these directories. The published list of PMTAs submitted by September 9, 2020 includes over 15M individual SKUs. This list has not been updated since 2021. Even if assuming over 99% of these products have been rejected, there are still the 1M non-tobacco nicotine PMTAs submitted by May 14, 2022 for which a list has never been provided by CTP. These products would presumably not be certified in many instances and it is not clear how the products in the directories would be verified other than by manufacturer attestation. Also, there are several manufacturers in various stages of litigation which further confuses the lists for retailers. Creation and maintenance of such directories will be a challenge, requiring resources to be diverted from other potentially more effective enforcement efforts.

Altria, Philip Morris International and British American Tobacco released 2023 annual earnings reports in recent weeks. The transition to non-combustible products is obvious and there was a marked increase in references to “nicotine” as opposed to “tobacco” in each report. Nothing groundbreaking here except the speed at which it is occurring has accelerated in the last year. Forward-looking statements seemed to confirm that transition. I used Microsoft Copilot to provide a quick synopsis of each company’s report. This is another excellent use-case for the utilization of AI.

-Altria aims to double its smoke-free net revenues to $5 billion from the 2022 base of $2.6 billion, with $2 billion coming from innovative smoke-free products.

-IQOS, has surpassed their best-selling cigarette brand, Marlboro, in terms of net revenues for the first time. IQOS is now the premium nicotine brand globally, achieving this milestone less than a decade since its launch. It currently accounts for more than 50% of PMI’s total net revenues in 25 markets.

-…we believe that each smokeless product category should be regulated differently, proportionate to the associated risk and according to the evidence base.

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